Bipolar DisorderBP ONEDAYNCT05178966
Evaluation of Efficiency of One Day Patient/Caregiver Psychoeducation on the Caregiver's Burden
A study testing Bp OneDay psychoeducation program in people with Bipolar Disorder and Caregiver Burden, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Bipolar disorder (BD) has a huge impact on the lives of patient and their relatives. Psychoeducation programs on BD has been shown to be effective on the burden of patients and their caregivers. However, actual programs appear to be incompatible with patients obligations and services requirements of the service. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Caregiver Burden
- What is being tested?
- Bp OneDay psychoeducation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2022to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Patient inclusion Criteria:
- Be over 18 years old;
- Meet the criteria for bipolar disorder (I, II, unspecified) according to the DSM-5 criteria;
- Be able to understand the nature, purpose and methodology of the study;
- Presence of a caregiver
Patient Exclusion Criteria:
- Subject unable to adhere to the group requirements (cognitive disorder, decompensated mood state ...);
- Subject protected by law (subject under guardianship and / or guardianship) or deprived of liberty by a judicial or administrative decision;
- Subject unable to understand, speak and write French;
- Subject in a period of exclusion from another protocol.
- Subject not having signed an informed consent
- Subject not affiliated with a social security scheme or such a scheme
Caregiver inclusion criteria ;
- Subject over 18 years old;
- Subject designated as a regular caregiver of a patient with bipolar disorder. A regular caregiver is a trusted person designated by the patient as being one of his main support, having knowledge of the diagnosis of bipolar disorder and who can be called upon in the context of care.
- Subject able to understand the nature, purpose and methodology of the study;
Caregiver exclusion criteria :
- Subject unable to adhere to the groupre quirements (cognitive disorder, decompensated mood state ...);
- Subject protected by law (subject under guardianship and / or curatorship) or deprived of liberty by a judicial or administrative decision ;
- Subject unable to understand, speak and write French;
- Subject in a period of exclusion from another protocol.
- Subject not having signed an informed consent
- Subject not affiliated with a social security scheme or such a scheme
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Montpellier
Montpellier
Gaëlle MARTINEZ-TARQUINI
About this study
Official title: Evaluation of the Effectiveness of a Day Patient-caregiver Psychoeducationnal Program on the Burden of Caregivers
Bipolar disorder (BD) has a huge impact on the lives of patient and their relatives. Psychoeducation programs on BD has been shown to be effective on the burden of patients and their caregivers. However, actual programs appear to be incompatible with patients obligations and services requirements of the service. The development of "minute" programs (in one day) is justified.
Read the detailed description
Bipolar disorder (BD) has a huge impact on patient lives and their relatives. BD psychoeducation has been shown to be effective on patient disease course and caregivers burden. However, the programs offered appear to be incompatible with the participants obligations and services requirements. In this context we wanted to develop a "minute" program (Bp one day).
Study participation includes 3 visits : inclusion visit and 2 follow up visits.
The main objective is to assess the effectiveness of day psychoeducational program (BP OneDay) on caregiver burden at one month according to the Zarit Caregiver Burden Interview (ZCBI) total score.
This study also aims to assess the effectiveness of BP OneDay on caregiver stigma, patient self-stigma and medication adherence, quality of life, and bipolar disorder knowledge.
The study is an open-label randomized controlled trial with two arms
Overall, 120 dyads will be recruited randomly affected in 2 groups :
- the interventional group will benefit from a day psychoeducational program : Bp oneDay
- the control group will be placed on the waiting list
The benefits expected from Bp OneDay are to reduce caregiver burden and stigma and improve knowledge about BD. For patients, we expect improve disease understanding, drug adherence and reduce self-stigmatization. If the results are promising, this program can be widely disseminated and thus increase cares' solution for patients and relatives in large urban centers.
- Conditions
- Bipolar Disorder, Caregiver Burden
- Being tested
- Bp OneDay psychoeducation program
- Keywords
- bipolar disorder, psychoeducation, caregivers, burden, stigmatization
- Medical subject headings
- Bipolar Disorder, Caregiver Burden, Stereotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bp OneDay psychoeducation programBehavioural
The BP One-Day Psychoeducation program is based on a single day of psychoeducation . This program was carried out by members of the bipolar expert center network in various hospitals of the network and included :
- Representation of BD
- Definition, diagnosis and awareness of the disorder
- Depressive, hypo / manic symptoms
- Vulnerability to BD causes of BD, risk factors for relapses
- Drug treatments, drug compliance and non-drug treatments
- Early detection of prodromal signs
- Communication techniques
Each BP One-Day psychoeducation session welcomes an average of ten participants (5 patients / 5 caregivers). At the end of the day, participants receive a booklet containing the main information of the day.
BP One-Day program is delivered by a nurse and a psychologist specialized in both BD and therapy group facilitation. A specialized psychiatrist intervenes in the section "Medication treatments and medication adherence" for a period of approximately one hour.
| Study group | Role | What they receive |
|---|---|---|
| Bp OneDay programm | Experimental | The BP One-Day program is based on a single day of psychoeducation . Receives: Behavioral: Bp OneDay psychoeducation program |
| Waiting List | No intervention | Patients assigned in control group will be placed in waiting list and will benefit from the program after their participation to this study. During study participation, they will receive treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
caregivers burden
evaluation of caregiver burden based on the Zarit Caregiver Burden Interview total score.
The Zarit Caregiver Burden Interview is a self-administered questionnaire assessing caregiver burden using 22 items. Five themes are examined: psychological and physical suffering, financial, relational and social difficulties. For each of the 22 items, the caregiver determines how often he feels a given emotion in the helping relationship. This frequency ranges from 0 "never" to 4 "Almost always". The overall score is obtained by adding all the items together, it varies from 0 to 88. The higher the score, the greater the burden felt by the caregiver.
Measured: Day65 for experimental group, Day35 for control group
Secondary outcomes (16)
caregivers stigmatization
évaluation of caregivers stigmatization using Affiliate stigma scale on caregivers of people with mental illness The Affiliate stigma scale on caregivers of people with mental illness is a self-questionnaire composed of 22 items assessing 3 dimensions of stigma : the cognitive, affective and behavioral dimension. Participants are asked to rate their level of agreement with the statements on a 4-point Likert scale (ranging from 1 "Strongly disagree" to 4 "Strongly agree). The total score ranges from 22 to 88. The higher the score, the more severe the stigma.
Measured: Day44 for experimental group, Day14 for control group
caregivers stigmatization
évaluation of caregivers stigmatization using Affiliate stigma scale on caregivers of people with mental illness The Affiliate stigma scale on caregivers of people with mental illness is a self-questionnaire composed of 22 items assessing 3 dimensions of stigma : the cognitive, affective and behavioral dimension. Participants are asked to rate their level of agreement with the statements on a 4-point Likert scale (ranging from 1 "Strongly disagree" to 4 "Strongly agree). The total score ranges from 22 to 88. The higher the score, the more severe the stigma.
Measured: Day65 for experimental group, Day35 for control group
Internalized Stigma of patients
evaluation of Internalized Stigma according to the Internalized Stigma of Mental Illness total score This self-questionnaire consists of 29 items. Each item is rated using a 4-points Likert scale ranging from 1 "Strongly disagree" to 4 "Strongly agree". The 29 items are grouped according to 5 themes: alienation (the fact of not feeling a full member of the society in which we live), approval of stereotypes, perceived discrimination, social withdrawal, and resistance to stigma. The higher the score, the more severe the self-stigma.
Measured: Day44 for experimental group, Day14 for control group
Internalized Stigma of patients
evaluation of Internalized Stigma according to the Internalized Stigma of Mental Illness total score This self-questionnaire consists of 29 items. Each item is rated using a 4-points Likert scale ranging from 1 "Strongly disagree" to 4 "Strongly agree". The 29 items are grouped according to 5 themes: alienation (the fact of not feeling a full member of the society in which we live), approval of stereotypes, perceived discrimination, social withdrawal, and resistance to stigma. The higher the score, the more severe the self-stigma.
Measured: Day65 for experimental group, Day35 for control group
Patient quality of life
Evaluation of patient quality of life according to the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form total score.
This 16-items self-administered questionnaire assesses the quality of life through the assessment of physical health, social relationships, family relationships, mood, libido, the ability to function on a daily basis, the ability to invest and enjoy leisure time, to work, the economic level, the place of life and the general feeling of well-being. The last two items assess satisfaction with treatment as well as satisfaction with life and are treated independently of the others. Each item is scored on a 5-point Likert scale and represents the level of satisfaction experienced over the last week. A calculation of the overall score is performed for items 1 to 14 (ranging from 14 to 70) and is expressed as a percentage (0-100). The higher the score, the better the quality of life.
Measured: Day44 for experimental group, Day14 for control group
Patient quality of life
Evaluation of patient quality of life according to the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form total score.
This 16-items self-administered questionnaire assesses the quality of life through the assessment of physical health, social relationships, family relationships, mood, libido, the ability to function on a daily basis, the ability to invest and enjoy leisure time, to work, the economic level, the place of life and the general feeling of well-being. The last two items assess satisfaction with treatment as well as satisfaction with life and are treated independently of the others. Each item is scored on a 5-point Likert scale and represents the level of satisfaction experienced over the last week. A calculation of the overall score is performed for items 1 to 14 (ranging from 14 to 70) and is expressed as a percentage (0-100). The higher the score, the better the quality of life.
Measured: Day65 for experimental group, Day35 for control group
caregivers quality of life
Evaluation of caregivers quality of life according to the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form total score.
This 16-items self-administered questionnaire assesses the quality of life through the assessment of physical health, social relationships, family relationships, mood, libido, the ability to function on a daily basis, the ability to invest and enjoy leisure time, to work, the economic level, the place of life and the general feeling of well-being. The last two items assess satisfaction with treatment as well as satisfaction with life and are treated independently of the others. Each item is scored on a 5-point Likert scale and represents the level of satisfaction experienced over the last week. A calculation of the overall score is performed for items 1 to 14 (ranging from 14 to 70) and is expressed as a percentage (0-100). The higher the score, the better the quality of life.
Measured: Day44 for experimental group, Day14 for control group
caregivers quality of life
Evaluation of caregivers quality of life according to the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form total score.
This 16-items self-administered questionnaire assesses the quality of life through the assessment of physical health, social relationships, family relationships, mood, libido, the ability to function on a daily basis, the ability to invest and enjoy leisure time, to work, the economic level, the place of life and the general feeling of well-being. The last two items assess satisfaction with treatment as well as satisfaction with life and are treated independently of the others. Each item is scored on a 5-point Likert scale and represents the level of satisfaction experienced over the last week. A calculation of the overall score is performed for items 1 to 14 (ranging from 14 to 70) and is expressed as a percentage (0-100). The higher the score, the better the quality of life.
Measured: Day65 for experimental group, Day35 for control group
Medication Adherence
Evaluation of patient medication adherence according to Medication Adherence Rating Scale total score.
This self-questionnaire has 10 yes / no items. The total score varies between 0 and 10. The higher the score, the better the compliance. This scale was created and is widely used in the psychiatric population.
Measured: Day44 for experimental group, Day14 for control group
Medication Adherence
Evaluation of patient medication adherence according to Medication Adherence Rating Scale total score.
This self-questionnaire has 10 yes / no items. The total score varies between 0 and 10. The higher the score, the better the compliance. This scale was created and is widely used in the psychiatric population.
Measured: Day65 for experimental group, Day35 for control group
Bipolar disorder Knowledge in patients
Evaluation of Bipolar Disorde knowledge in patients according to "Quizz BP" total score.
This self-administered questionnaire is composed of twenty true or false questions. It addresses different themes: occurrence, etiology, semiology, factors triggering episodes, comorbidities, treatments. The overall score fluctuates between 0 and 20. Although this test has not been validated, it has already been used in several published works
Measured: Day44 for experimental group, Day14 for control group
Bipolar disorder Knowledge in patients
Evaluation of Bipolar Disorde knowledge in patients according to "Quizz BP" total score.
This self-administered questionnaire is composed of twenty true or false questions. It addresses different themes: occurrence, etiology, semiology, factors triggering episodes, comorbidities, treatments. The overall score fluctuates between 0 and 20. Although this test has not been validated, it has already been used in several published works
Measured: Day65 for experimental group, Day35 for control group
Bipolar disorder Knowledge in caregivers
Evaluation of Bipolar Disorde knowledge in caregivers according to "Quizz BP" total score.
This self-administered questionnaire is composed of twenty true or false questions. It addresses different themes: occurrence, etiology, semiology, factors triggering episodes, comorbidities, treatments. The overall score fluctuates between 0 and 20. Although this test has not been validated, it has already been used in several published works
Measured: Day44 for experimental group, Day14 for control group
Bipolar disorder Knowledge in caregivers
Evaluation of Bipolar Disorde knowledge in caregivers according to "Quizz BP" total score.
This self-administered questionnaire is composed of twenty true or false questions. It addresses different themes: occurrence, etiology, semiology, factors triggering episodes, comorbidities, treatments. The overall score fluctuates between 0 and 20. Although this test has not been validated, it has already been used in several published works
Measured: Day65 for experimental group, Day35 for control group
Patient satisfaction
Evaluation of patient satisfaction with the group according to a liker score ranged from 0 "absolutely not satisfied" to 10 "Extremely satisfied"
Measured: Day44 for experimental group, Day14 for control group
caregiver satisfaction
Evaluation of caregiver satisfaction with the group according to a liker score ranged from 0 "absolutely not satisfied" to 10 "Extremely satisfied"
Measured: Day44 for experimental group, Day14 for control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start9 Nov 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178966
- Sponsor's protocol ID
- 2021-A01317-34
- Other IDs
- 2021-A01317-34
- Acronym
- BP ONEDAY
- Status last verified
- Aug 2024
- First submitted
- 24 Sep 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Day Patient-caregiver Psychoeducationnal Program on the Burden of Caregivers
- ClinicalTrials.gov ID
- NCT05178966
- Acronym / sponsor ID
- BP ONEDAY / 2021-A01317-34
- Conditions
- Bipolar Disorder, Caregiver Burden
- Keywords
- bipolar disorder, psychoeducation, caregivers, burden, stigmatization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bipolar disorder (BD) has a huge impact on the lives of patient and their relatives. Psychoeducation programs on BD has been shown to be effective on the burden of patients and their caregivers. However, actual programs appear to be incompatible with patients obligations and services requirements of the service. The development of "minute" programs (in one day) is justified.
Detailed description
Bipolar disorder (BD) has a huge impact on patient lives and their relatives. BD psychoeducation has been shown to be effective on patient disease course and caregivers burden. However, the programs offered appear to be incompatible with the participants obligations and services requirements. In this context we wanted to develop a "minute" program (Bp one day).
Study participation includes 3 visits : inclusion visit and 2 follow up visits.
The main objective is to assess the effectiveness of day psychoeducational program (BP OneDay) on caregiver burden at one month according to the Zarit Caregiver Burden Interview (ZCBI) total score.
This study also aims to assess the effectiveness of BP OneDay on caregiver stigma, patient self-stigma and medication adherence, quality of life, and bipolar disorder knowledge.
The study is an open-label randomized controlled trial with two arms
Overall, 120 dyads will be recruited randomly affected in 2 groups :
- the interventional group will benefit from a day psychoeducational program : Bp oneDay
- the control group will be placed on the waiting list
The benefits expected from Bp OneDay are to reduce caregiver burden and stigma and improve knowledge about BD. For patients, we expect improve disease understanding, drug adherence and reduce self-stigmatization. If the results are promising, this program can be widely disseminated and thus increase cares' solution for patients and relatives in large urban centers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bp OneDay programm | Experimental | Behavioral: Bp OneDay psychoeducation programThe BP One-Day program is based on a single day of psychoeducation . |
| Waiting List | No intervention | –Patients assigned in control group will be placed in waiting list and will benefit from the program after their participation to this study. During study participation, they will receive treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bp OneDay psychoeducation programThe BP One-Day Psychoeducation program is based on a single day of psychoeducation . This program was carried out by members of the bipolar expert center network in various hospitals of the network and included : * Representation of BD * Definition, diagnosis and awareness of the disorder * Depressive, hypo / manic symptoms * Vulnerability to BD causes of BD, risk factors for relapses * Drug treatments, drug compliance and non-drug treatments * Early detection of prodromal signs * Communication techniques Each BP One-Day psychoeducation session welcomes an average of ten participants (5 patients / 5 caregivers). At the end of the day, participants receive a booklet containing the main information of the day. BP One-Day program is delivered by a nurse and a psychologist specialized in both BD and therapy group facilitation. A specialized psychiatrist intervenes in the section "Medication treatments and medication adherence" for a period of approximately one hour. | Behavioural | Bp OneDay programm |
Primary outcome
caregivers burden
Time frame: Day65 for experimental group, Day35 for control group
evaluation of caregiver burden based on the Zarit Caregiver Burden Interview total score. The Zarit Caregiver Burden Interview is a self-administered questionnaire assessing caregiver burden using 22 items. Five themes are examined: psychological and physical suffering, financial, relational and social difficulties. For each of the 22 items, the caregiver determines how often he feels a given emotion in the helping relationship. This frequency ranges from 0 "never" to 4 "Almost always". The overall score is obtained by adding all the items together, it varies from 0 to 88. The higher the score, the greater the burden felt by the caregiver.
16 secondary outcomes
caregivers stigmatization
Time frame: Day44 for experimental group, Day14 for control group
caregivers stigmatization
Time frame: Day65 for experimental group, Day35 for control group
Internalized Stigma of patients
Time frame: Day44 for experimental group, Day14 for control group
Internalized Stigma of patients
Time frame: Day65 for experimental group, Day35 for control group
Patient quality of life
Time frame: Day44 for experimental group, Day14 for control group
Patient quality of life
Time frame: Day65 for experimental group, Day35 for control group
caregivers quality of life
Time frame: Day44 for experimental group, Day14 for control group
caregivers quality of life
Time frame: Day65 for experimental group, Day35 for control group
Medication Adherence
Time frame: Day44 for experimental group, Day14 for control group
Medication Adherence
Time frame: Day65 for experimental group, Day35 for control group
Bipolar disorder Knowledge in patients
Time frame: Day44 for experimental group, Day14 for control group
Bipolar disorder Knowledge in patients
Time frame: Day65 for experimental group, Day35 for control group
Bipolar disorder Knowledge in caregivers
Time frame: Day44 for experimental group, Day14 for control group
Bipolar disorder Knowledge in caregivers
Time frame: Day65 for experimental group, Day35 for control group
Patient satisfaction
Time frame: Day44 for experimental group, Day14 for control group
caregiver satisfaction
Time frame: Day44 for experimental group, Day14 for control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bp OneDay psychoeducation program in people with Bipolar Disorder and Caregiver Burden, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathlyne DUPUIS MAURIN (+33467335663, k-dupuis@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caregivers burden (time frame: Day65 for experimental group, Day35 for control group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.